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Could a single iron infusion help heart failure patients feel better?

NCT ID NCT07643818

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 25, 2026 · Updated 4 times

Summary

This study tests whether a single intravenous dose of iron (ferric derisomaltose) can improve symptoms, exercise ability, and quality of life in 150 adults with a type of heart failure called HFpEF who also have iron deficiency. Participants will receive either the iron infusion or a placebo and be followed for 12 weeks. The main goal is to see if they can walk farther in six minutes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ferric derisomaltose (Monofer) given as a single intravenous infusion
What this could lead to
If it works, this could provide a simple treatment to improve daily life and physical ability for people with a common type of heart failure.
What could go wrong
This is a small, early-phase trial (150 people) that hasn't started yet. It may not show clear benefit, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥18 years. * Willing and able to provide written informed consent. * Clinical diagnosis of heart failure with ejection fraction ≥40%. * New York Heart Association (NYHA) class II or III symptoms at the time of randomisation. * Ambulatory for at least 7 days prior to randomisation. * Iron deficiency defined as transferrin saturation (TSAT) \<20% or serum iron ≤13umol/L * Haemoglobin ≤15.0 g/dL. * Baseline 6-minute walk distance \<450 metres. Exclusion Criteria: * Unable or unwilling to provide informed consent. * Prior documented left ventricular ejection fraction (LVEF) \<40%. * Clinical signs or symptoms of active infection, including fever \>38°C. * Intravenous iron therapy, erythropoietin therapy, or blood transfusion within the previous 3 months. * Concurrent immunosuppressive therapy. * Known iron overload syndrome or haemochromatosis, or first-degree relative with haemochromatosis. * Known hypersensitivity to ferric derisomaltose (Monofer) or other intravenous iron preparations. * Known bleeding anaemia or haemolytic anaemia. * Any condition precluding exercise testing, including decompensated heart failure, unstable angina, obstructive cardiomyopathy, severe uncorrected valvular disease, significant musculoskeletal disease, or uncontrolled bradyarrhythmias or tachyarrhythmias. * Probable alternative explanation for symptoms in the opinion of the investigator, including severe obesity, primary pulmonary hypertension, or chronic obstructive pulmonary disease (COPD). * Severe COPD defined as FEV1 \<50%, requirement for home oxygen therapy, or chronic oral steroid therapy. * Renal replacement therapy or estimated glomerular filtration rate (eGFR) \<15 mL/min/1.73m². * Uncontrolled atrial fibrillation with resting heart rate \>110 beats/minute. * Uncontrolled hypertension with blood pressure \>180/110 mmHg. * Concurrent therapy with an erythropoiesis-stimulating agent. * Known active malignancy. * Known HIV infection or active hepatitis infection. * Pregnancy. * Decompensated liver disease.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Jersey General Hospital

    Saint Helier, Jersey

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